Retract Gingival Retraction/Hemostatic Paste
FDA 510(k) K113839 · Parkell, Inc.
510(k) numberK113839
Submission
- Device name
- Retract Gingival Retraction/Hemostatic Paste
- Applicant
- Parkell, Inc.
Edgewood, NY, US - Received
- December 28, 2011
- Decision date
- April 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MVL – Cord, Retraction
- Device class
- Unclassified
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Questions and answers
When was Retract Gingival Retraction/Hemostatic Paste cleared by the FDA?
Retract Gingival Retraction/Hemostatic Paste (K113839) received a 510(k) decision of Substantially Equivalent on April 12, 2012, 106 days after the submission was received.
What is the product code of K113839?
The FDA product code is MVL – Cord, Retraction, a Unclassified device.